Feasibility and Efficacy of a Mindfulness-enhanced Positive Affect Induction for Experimentally Induced Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Pain Tolerance, assessed by duration of CPT
Study Overview
Brief Summary
The goal of this clinical trial is to test if a mindfulness-enhanced positive affect induction (MPAI) works well to reduce pain intensity and pain unpleasantness from a cold water pain test in undergraduate college students who do not endorse ongoing medical or mental health diagnoses. The main questions it aims to answer are:
- Is the MPAI a feasible and acceptable psychological technique for managing brief pain?
- Does the MPAI work well to reduce pain intensity and unpleasantness from experimentally induced brief pain, compared to those using a breathing meditation or those instructed to respond naturally.
- Does using the MPAI work well to improve confidence in self-managing brief pain?
Participants will be asked to complete questionnaires about their sleep, pain beliefs, and emotions after consenting to participate and at the end of the study session. They will then be randomized to either:
- Use the MPAI for managing pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius).
- Use a breathing meditation for managing pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius).
- Respond naturally to pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius).
Researchers will compare the MPAI group to the breathing meditation and natural response groups to see if the MPAI group reports less pain from the cold water test and
Detailed Description
The purpose of the study is to assess the following aims:
Aim 1: Examine the feasibility and acceptability of a mindfulness-enhanced positive affect induction (MPAI) for improving the experience of experimentally-induced pain.
Aim 2: Examine the efficacy of the MPAI in reducing pain intensity and increasing pain tolerance.
Aim 3: Examine change in self-efficacy in pain management from before and after using the MPAI.
Recruitment:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- None
Masking Description
Research assistant will be aware of participant randomization, as necessary for providing the correct study instructions and procedures (e.g., pain psycho-education and meditation audio recording). Participants will not be masked, as they will receive specific instructions on and audio recorded meditation practice based on their group.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •University of Colorado Students
- •Age 18-65
- •Fluent in written and spoken English
Exclusion Criteria
- •Presence of an untreated mood or psychiatric disorder
- •Presence of a current chronic pain condition
- •Presence or history of Reynaud's syndrome, peripheral neuropathy, or unstable heart condition (including myocardial infarction, abnormal heart rhythms, or hypertension)
- •Current use of prescription pain medication, high-dose anti-psychotics, selective serotonin re-uptake inhibitors (SSRIs), benzodiazepines, or gabapentin
- •Day-of over the counter pain medication use
- •Marijuana, Cannabidiol (CBD), or psilocybin use within three days of study participation (recency of use assessed via self-report)
- •Food, caffeine, and nicotine are not to be had within 30 minutes of cold pressor test (nicotine patch not exclusionary due to stable/consistent state).
Outcomes
Primary Outcomes
Pain Tolerance, assessed by duration of CPT
Time Frame: Pain tolerance, assessed by duration of the CPT, will be recorded immediately after the intervention (i.e., the CPT), during the post-CPT survey set
Pain tolerance will be assessed via the amount of time (i.e., number of seconds) until participants remove their hand from the cold water during the cold pressor test (CPT). CPT duration will be timed via a stopwatch and will begin when the participant's hand is submerged in the cold water up to the wrist and will stop immediately when the hand is removed. More time in the water will be indicative of greater pain tolerance. Water temperature will be maintained at 5 degrees Celsius to optimize potential for pain intensity and tolerance during the CPT measures. Longer duration of the CPT will indicate higher pain tolerance.
Pain Intensity, assessed by VAS
Time Frame: Pain intensity will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
Pain intensity will be assessed via two items: "Please rate your peak pain intensity experienced during the cold water test" and "Please rate your average pain intensity experienced during the cold water test". Each item response will be rated on a 0-100 visual analog scale (VAS). "0" will indicate no pain intensity and "100" will indicate intolerable pain intensity, with higher scores indicating higher pain intensity.
Pain Unpleasantness, assessed by VAS
Time Frame: Pain unpleasantness will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
Pain unpleasantness will be assessed via two items: "Please rate your peak pain unpleasantness experienced during the cold water test (e.g., how bothersome you found the pain from the cold water test)" and "Please rate your average pain unpleasantness experienced during the cold water test (e.g., how bothersome you found the pain from the cold water test)". Each item response will be rated on a 0-100 visual analog scale (VAS). "0" will indicate no pain unpleasantness and "100" will indicate intolerable pain unpleasantness, with higher scores indicating higher pain unpleasantness.
Acceptability of MPAI as a technique for reducing pain, assessed by six questions on satisfaction and usefulness of the MPAI
Time Frame: Acceptability questions will be assessed immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
Acceptability will be assessed via the following items: "How acceptable did you find the coping strategy to be?", "How satisfied are you with the coping strategy?", "How useful was the coping strategy?", "Was the coping strategy easy to understand?", "Was the coping strategy easy to use?", "How likely are you to use the coping strategy you learned today?". Item responses will be given on a 0-6 seven-point Likert scale with anchors varying by the item (e.g. Not at all Acceptable/Very Acceptable, Not at all Satisfied/Very Satisfied, Not at all Useful/Very Useful, Extremely Difficult to Understand/Very Easy to Understand, Extremely Difficult to Use/Very Easy to Use, and Not at all Likely/Highly Likely). Means, standard deviations, and percentages of PBQ items will be calculated. Good acceptability will be considered by high mean percentage ratings (≥80%) for each item, with higher mean percentages indicating greater acceptability.
Self-Efficacy in Pain Management assessed by change in Pain Beliefs Questionnaire (PBQ) total scores
Time Frame: Self-efficacy in pain management, assessed by change in PBQ total scores will be assessed during the baseline survey set and the post-CPT survey set (i.e., immediately after the intervention)
Self-efficacy in pain management will be assessed via the Pain Beliefs Questionnaire (PBQ). The PBQ is a nine-item instrument assessing beliefs in ability to manage pain, as well as ability to learn and utilize a pain self-management technique, with high internal consistency (Chronbach's alpha = 0.89). Example items include: "The degree of pain I experience is mostly up to me" and "How well will you be able to focus your attention on the coping strategy while in pain?". Item responses are given on a 1-7 seven-point scale with anchors such as True/False, Agree/Disagree, Difficult/Easy, Very Little Control/Complete Control, Very Uncertain/Very Certain, Not at all Well/Very well, and Not at all Confident/Very Confident. Total PBQ scores are calculated as the mean of all nine items, with higher scores representing higher levels of self-efficacy in pain management
Feasibility beliefs of MPAI as implementable and efficacious for pain management, assessed by three PBQ items
Time Frame: Feasibility measures (i.e., the PBQ) will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
Feasibility beliefs of MPAI in pain management will be assessed via three items from the Pain Beliefs Questionnaire (PBQ): "Would you be able to perform the coping strategy while in pain?", 2) "How well will you be able to focus your attention on the coping strategy while in pain?", 3) "How confident are you that you will be able to use the coping strategy to reduce your pain while in pain?". Item responses will be given on a 0-6 seven-point Likert scale with anchors varying by the item (e.g. Not at all Confident/Very Confident, Not at all Well/Very well, and Very Uncertain/Very Certain). Means and percentages will be calculated. Good feasibility with PBQ items will be considered by high mean percentage ratings (≥80%) for each item, with higher mean percentages will indicating greater feasibility (see Outcome 6 below for detail on PBQ). Although the PBQ will be assessed at multiple time points, feasibility analyses will only include items assessed immediately after the intervention.
Secondary Outcomes
- Positive Affect Manipulation Check(The positive affect manipulation check measure will be assessed pre-intervention [i.e., immediately after practice of the respective meditation, immediately before using the respective meditation during the cold pressor task (CPT)])
- Present-Moment Affect, assessed by affect ratings(Present-moment affect will be collected during baseline, before the CPT (after condition practice), immediately following the CPT)